Phase 4
Completed N=8
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00442767 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone — 205; 993 mmol*L/min
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.
The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone |
205; 993 | — |
| SECONDARY Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone. |
6060; 7575 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes only
- Diagnosed with T1DM for at least 1 year
- HbA1C less than or equal to 8.5%
- Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump
- Hemoglobin equal to or greater than 12mg/dL
- Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism
- Negative pregnancy test, in the case of females
Exclusion Criteria
- Lack of supportive family
- Evidence or history of chemical abuse
- BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age
- Patient who is poorly compliant with current insulin management and/or Prescribed self blood glucose monitoring
- Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months
- Have hypoglycemia unawareness
- Have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility
- Pregnant or lactating patients, or patients planning on becoming pregnant
Data sourced from ClinicalTrials.gov (NCT00442767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.